Chronic Mechanical Low Back PainNCT07258927
Neuromuscular Inhibition vs Muscle Energy Techniques With Core Exercises in Mechanical Low Back Pain
A study testing Core Stabilization Exercise (CSE), Integrated Neuromuscular Inhibition Technique (INIT) and Muscle Energy Technique (MET) in people with Chronic Mechanical Low Back Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Chronic mechanical low back pain (CMLBP) is a common clinical problem that affects physical function, spinal mobility, and quality of life. Manual therapy techniques such as Integrated Neuromuscular Inhibition Technique (INIT) and Muscle Energy Technique (MET) are frequently used in clinical practice to reduce pain… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Mechanical Low Back Pain
- What is being tested?
- Core Stabilization Exercise (CSE), Integrated Neuromuscular Inhibition Technique (INIT) and Muscle Energy Technique (MET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65
- Diagnosed chronic mechanical low back pain (>3 months)
- Pain localized between T12 and gluteal fold
- Ability to follow exercise instructions
- Voluntary consent
Who cannot join
- Spine surgery history
- Herniated disc with neurological deficit
- Systemic neuromuscular or rheumatologic disease
- Acute lumbar trauma
- Pregnancy
- Current participation in another clinical trial
- Use of analgesics, muscle relaxants, or physiotherapy within the past 4 weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa, Graduate School / Doctoral Program
Istanbul, BAŞAKŞEHİR, 34490
About this study
Official title: Comparison of the Effects of Integrated Neuromuscular Inhibition and Muscle Energy Techniques Combined With Core Stabilization Exercises in Patients With Chronic Mechanical Low Back Pain
Chronic mechanical low back pain (CMLBP) is a common clinical problem that affects physical function, spinal mobility, and quality of life. Manual therapy techniques such as Integrated Neuromuscular Inhibition Technique (INIT) and Muscle Energy Technique (MET) are frequently used in clinical practice to reduce pain and improve function. Core stabilization exercises (CSE) have also been reported to enhance spinal stability and neuromuscular control. However, limited evidence exists comparing the combined effects of these manual therapy techniques with core stabilization exercise on clinical outcomes in individuals with CMLBP.
This randomized controlled clinical study aims to compare the effects of CSE combined with INIT and CSE combined with MET on pain intensity, functional disability, lumbar range of motion, psychosocial status, muscle endurance, and quality of life in adults with chronic mechanical low back pain.
Read more
Participants will be randomly assigned to one of two groups: (1) CSE + INIT or (2) CSE + MET. Each group will receive treatment two times per week for six weeks. Pain severity, functional status, lumbar mobility, patient-reported outcomes, and muscle endurance will be assessed at baseline, immediately after the intervention, and at follow-up.
The results of this study will help determine whether INIT or MET provides additional benefit when combined with core stabilization exercise for improving symptoms and function in individuals with chronic mechanical low back pain.
Read the detailed description
Chronic mechanical low back pain (CMLBP) is one of the most prevalent musculoskeletal disorders worldwide. It is characterized by pain originating from the lumbar spine or surrounding structures without a specific underlying pathology. The condition often results in pain, functional disability, reduced spinal mobility, impaired muscle performance, and psychosocial effects, which can negatively influence quality of life.
Manual therapy modalities are commonly used in rehabilitation to alleviate symptoms and improve mobility in individuals with CMLBP. The Integrated Neuromuscular Inhibition Technique (INIT) is a multimodal approach that includes strain-counterstrain, trigger point release, and muscle energy technique to reduce muscle tension, deactivate tender points, and improve neuromuscular balance. Muscle Energy Technique (MET) is an osteopathic manual therapy approach that uses voluntary muscle contractions against resistance to relax hypertonic muscles, increase joint mobility, and reduce pain. Both techniques are frequently used in practice, yet their comparative effectiveness when combined with core stabilization exercise remains unclear.
Core Stabilization Exercises (CSE) focus on enhancing the strength, endurance, and motor control of the deep spinal stabilizing muscles. They are widely recommended to improve spinal stability, decrease pain, and enhance function in individuals with CMLBP.
This randomized controlled study aims to evaluate and compare the effectiveness of CSE combined with INIT versus CSE combined with MET on multiple clinical outcomes in individuals with CMLBP. Participants who meet the inclusion criteria will be randomly assigned to one of two intervention groups:
CSE + INIT Group: will receive integrated neuromuscular inhibition techniques along with core stabilization exercises.
CSE + MET Group: will receive muscle energy techniques along with core stabilization exercises.
Both groups will receive treatment twice weekly for six weeks. Outcome measures will include:
Pain intensity (e.g., Visual Analog Scale)
Functional disability (e.g., Oswestry Disability Index)
Lumbar range of motion
Muscle endurance
Psychosocial status
Quality of life
Assessments will be conducted at three time points: baseline, post-treatment, and follow-up.
The primary hypothesis is that both treatment approaches will lead to improvements in pain and function, but the combination of CSE with INIT may demonstrate superior outcomes compared to CSE with MET.
The findings of this study will provide valuable knowledge to clinicians regarding optimal manual therapy integration with exercise for individuals with chronic mechanical low back pain. This may contribute to evidence-based clinical decision-making and improved patient outcomes.
- Conditions
- Chronic Mechanical Low Back Pain
- Being tested
- Core Stabilization Exercise (CSE), Integrated Neuromuscular Inhibition Technique (INIT), Muscle Energy Technique (MET)
- Keywords
- Chronic mechanical low back pain, Integrated neuromuscular inhibition technique, Respiratory muscle strength, Core stabilization exercises, Muscle energy technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization Exercise (CSE)Behavioural
Supervised core stabilization exercise program focusing on activation of deep trunk stabilizers (transversus abdominis and multifidus). Training includes isolated activation, quadruped exercises, bridging variations, and functional stabilization drills. Sessions last 45-60 minutes, 3 times per week for 6 weeks and are delivered by a physiotherapist.
Integrated Neuromuscular Inhibition Technique (INIT)Behavioural
Manual therapy combining ischemic compression, strain-counterstrain, and muscle energy techniques applied to active trigger points in the lumbar/pelvic region. Target muscles include quadratus lumborum, iliopsoas, hamstrings, and erector spinae. Sessions last 45-60 minutes with integrated exercise, 3 times per week for 6 weeks and are administered by a physiotherapist.
Muscle Energy Technique (MET)Behavioural
Manual technique using therapist-guided isometric contraction of shortened muscles followed by relaxation and passive stretch. Target muscles include quadratus lumborum, iliopsoas, hamstrings, and erector spinae. Sessions last 45-60 minutes with integrated exercise, 3 times per week for 6 weeks and are administered by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Core Stabilization + INIT | Experimental | Participants receive Core Stabilization Exercises (CSE) combined with Integrated Neuromuscular Inhibition Technique (INIT). Sessions are administered by a physiotherapist, 45-60 minutes per session, 3 times per week for 6 weeks. INIT includes ischemic compression, strain-counterstrain, and muscle energy techniques applied to active trigger points. Receives: Behavioral: Core Stabilization Exercise (CSE); Behavioral: Integrated Neuromuscular Inhibition Technique (INIT) |
| Core Stabilization + MET | Active comparator | Participants receive Core Stabilization Exercises (CSE) combined with Muscle Energy Technique (MET) delivered by a physiotherapist, 45-60 minutes per session, 3 times per week for 6 weeks. Manual techniques target trigger points of quadratus lumborum, iliopsoas, hamstring, and erector spinae muscles. Receives: Behavioral: Core Stabilization Exercise (CSE); Behavioral: Muscle Energy Technique (MET) |
| Core Stabilization Only | Active comparator | Participants perform only Core Stabilization Exercises (CSE), emphasizing activation of deep stabilizers (transversus abdominis and multifidus) with progressive exercises performed under physiotherapist supervision, 45-60 minutes per session, 3 times per week for 6 weeks. Receives: Behavioral: Core Stabilization Exercise (CSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold (PPT)
Pressure pain threshold will be assessed using a handheld pressure algometer at standardized lumbar paraspinal trigger point regions. PPT is defined as the minimum pressure that produces pain. Higher values indicate reduced pain sensitivity.
Units of Measure: Kilograms per square centimeter (kg/cm²)
Measured: Baseline, Week 6 (post-treatment)
Secondary outcomes (1)
Disability Level (Oswestry Disability Index)
Functional disability will be measured using the Oswestry Disability Index (ODI). Scores range from 0-100%, with higher scores indicating greater disability.
Outcome Measure: Disability Level (Oswestry Disability Index)
Functional disability will be assessed using the Oswestry Disability Index (ODI). The ODI score ranges from 0 to 100 points, with higher scores indicating greater disability and lower scores indicating less disability.
The ODI evaluates a participant's level of functional impairment due to low back pain, including activities such as:
Pain intensity
Personal care
Lifting
Walking
Sitting
Standing
Sleeping
Sex life Units of Measure: Percent (%)
Social life
Traveling
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Apr 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into three parallel groups: 1. CSE + INIT 2. CSE + MET 3. CSE alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Agırtmış, Istanbul University - Cerrahpasa
- Investigators
- RÜSTEM MUSTAFAOĞLU, Study director, Istanbul University-Cerrahpaşa - Graduate School of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258927
- Sponsor's protocol ID
- IUC-GSHS-2025-INITKET-01
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Integrated Neuromuscular Inhibition and Muscle Energy Techniques Combined With Core Stabilization Exercises in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT07258927
- Acronym / sponsor ID
- IUC-GSHS-2025-INITKET-01
- Conditions
- Chronic Mechanical Low Back Pain
- Keywords
- Chronic mechanical low back pain, Integrated neuromuscular inhibition technique, Respiratory muscle strength, Core stabilization exercises, Muscle energy technique
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic mechanical low back pain (CMLBP) is a common clinical problem that affects physical function, spinal mobility, and quality of life. Manual therapy techniques such as Integrated Neuromuscular Inhibition Technique (INIT) and Muscle Energy Technique (MET) are frequently used in clinical practice to reduce pain and improve function. Core stabilization exercises (CSE) have also been reported to enhance spinal stability and neuromuscular control. However, limited evidence exists comparing the combined effects of these manual therapy techniques with core stabilization exercise on clinical outcomes in individuals with CMLBP.
This randomized controlled clinical study aims to compare the effects of CSE combined with INIT and CSE combined with MET on pain intensity, functional disability, lumbar range of motion, psychosocial status, muscle endurance, and quality of life in adults with chronic mechanical low back pain.
Participants will be randomly assigned to one of two groups: (1) CSE + INIT or (2) CSE + MET. Each group will receive treatment two times per week for six weeks. Pain severity, functional status, lumbar mobility, patient-reported outcomes, and muscle endurance will be assessed at baseline, immediately after the intervention, and at follow-up.
The results of this study will help determine whether INIT or MET provides additional benefit when combined with core stabilization exercise for improving symptoms and function in individuals with chronic mechanical low back pain.
Detailed description
Chronic mechanical low back pain (CMLBP) is one of the most prevalent musculoskeletal disorders worldwide. It is characterized by pain originating from the lumbar spine or surrounding structures without a specific underlying pathology. The condition often results in pain, functional disability, reduced spinal mobility, impaired muscle performance, and psychosocial effects, which can negatively influence quality of life.
Manual therapy modalities are commonly used in rehabilitation to alleviate symptoms and improve mobility in individuals with CMLBP. The Integrated Neuromuscular Inhibition Technique (INIT) is a multimodal approach that includes strain-counterstrain, trigger point release, and muscle energy technique to reduce muscle tension, deactivate tender points, and improve neuromuscular balance. Muscle Energy Technique (MET) is an osteopathic manual therapy approach that uses voluntary muscle contractions against resistance to relax hypertonic muscles, increase joint mobility, and reduce pain. Both techniques are frequently used in practice, yet their comparative effectiveness when combined with core stabilization exercise remains unclear.
Core Stabilization Exercises (CSE) focus on enhancing the strength, endurance, and motor control of the deep spinal stabilizing muscles. They are widely recommended to improve spinal stability, decrease pain, and enhance function in individuals with CMLBP.
This randomized controlled study aims to evaluate and compare the effectiveness of CSE combined with INIT versus CSE combined with MET on multiple clinical outcomes in individuals with CMLBP. Participants who meet the inclusion criteria will be randomly assigned to one of two intervention groups:
CSE + INIT Group: will receive integrated neuromuscular inhibition techniques along with core stabilization exercises.
CSE + MET Group: will receive muscle energy techniques along with core stabilization exercises.
Both groups will receive treatment twice weekly for six weeks. Outcome measures will include:
Pain intensity (e.g., Visual Analog Scale)
Functional disability (e.g., Oswestry Disability Index)
Lumbar range of motion
Muscle endurance
Psychosocial status
Quality of life
Assessments will be conducted at three time points: baseline, post-treatment, and follow-up.
The primary hypothesis is that both treatment approaches will lead to improvements in pain and function, but the combination of CSE with INIT may demonstrate superior outcomes compared to CSE with MET.
The findings of this study will provide valuable knowledge to clinicians regarding optimal manual therapy integration with exercise for individuals with chronic mechanical low back pain. This may contribute to evidence-based clinical decision-making and improved patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized into three parallel groups: 1. CSE + INIT 2. CSE + MET 3. CSE alone.
| Arm | Type | Receives |
|---|---|---|
| Core Stabilization + INIT | Experimental | Behavioral: Core Stabilization Exercise (CSE), Behavioral: Integrated Neuromuscular Inhibition Technique (INIT)Participants receive Core Stabilization Exercises (CSE) combined with Integrated Neuromuscular Inhibition Technique (INIT). Sessions are administered by a physiotherapist, 45-60 minutes per session, 3 times per week for 6 weeks. INIT includes ischemic compression, strain-counterstrain, and muscle energy techniques applied to active trigger points. |
| Core Stabilization + MET | Active comparator | Behavioral: Core Stabilization Exercise (CSE), Behavioral: Muscle Energy Technique (MET)Participants receive Core Stabilization Exercises (CSE) combined with Muscle Energy Technique (MET) delivered by a physiotherapist, 45-60 minutes per session, 3 times per week for 6 weeks. Manual techniques target trigger points of quadratus lumborum, iliopsoas, hamstring, and erector spinae muscles. |
| Core Stabilization Only | Active comparator | Behavioral: Core Stabilization Exercise (CSE)Participants perform only Core Stabilization Exercises (CSE), emphasizing activation of deep stabilizers (transversus abdominis and multifidus) with progressive exercises performed under physiotherapist supervision, 45-60 minutes per session, 3 times per week for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-65
- Diagnosed chronic mechanical low back pain (>3 months)
- Pain localized between T12 and gluteal fold
- Ability to follow exercise instructions
- Voluntary consent
Key exclusion criteria (7 listed)
- Spine surgery history
- Herniated disc with neurological deficit
- Systemic neuromuscular or rheumatologic disease
- Acute lumbar trauma
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Stabilization Exercise (CSE)Supervised core stabilization exercise program focusing on activation of deep trunk stabilizers (transversus abdominis and multifidus). Training includes isolated activation, quadruped exercises, bridging variations, and functional stabilization drills. Sessions last 45-60 minutes, 3 times per week for 6 weeks and are delivered by a physiotherapist. | Behavioural | Core Stabilization + INIT, Core Stabilization + MET, Core Stabilization Only |
| Integrated Neuromuscular Inhibition Technique (INIT)Manual therapy combining ischemic compression, strain-counterstrain, and muscle energy techniques applied to active trigger points in the lumbar/pelvic region. Target muscles include quadratus lumborum, iliopsoas, hamstrings, and erector spinae. Sessions last 45-60 minutes with integrated exercise, 3 times per week for 6 weeks and are administered by a physiotherapist. | Behavioural | Core Stabilization + INIT |
| Muscle Energy Technique (MET)Manual technique using therapist-guided isometric contraction of shortened muscles followed by relaxation and passive stretch. Target muscles include quadratus lumborum, iliopsoas, hamstrings, and erector spinae. Sessions last 45-60 minutes with integrated exercise, 3 times per week for 6 weeks and are administered by a physiotherapist. | Behavioural | Core Stabilization + MET |
Primary outcome
Pressure Pain Threshold (PPT)
Time frame: Baseline, Week 6 (post-treatment)
Pressure pain threshold will be assessed using a handheld pressure algometer at standardized lumbar paraspinal trigger point regions. PPT is defined as the minimum pressure that produces pain. Higher values indicate reduced pain sensitivity. Units of Measure: Kilograms per square centimeter (kg/cm²)
1 secondary outcome
Disability Level (Oswestry Disability Index)
Time frame: Baseline, Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- General study protocol and information, including Istanbul University Cerrahpaşa Ethics Committee approval and protocol details.Link provided by the sponsor.
- Official clinical trials registry providing general study information.Link provided by the sponsor.
- Istanbul University institutional resources and study-related documentation.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RÜSTEM MUSTAFAOĞLU study director
Istanbul University-Cerrahpaşa - Graduate School of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization Exercise (CSE), Integrated Neuromuscular Inhibition Technique (INIT) and Muscle Energy Technique (MET) in people with Chronic Mechanical Low Back Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (PPT) (time frame: Baseline, Week 6 (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.